Change is a form-driven workflow (ECR, ECO, Deviation, Concession Note, OFI). Each change uses required sections (problem/need, impact/risk, proposed change, approvals, implementation, verification) that people edit and save. Every save creates a time-stamped draft revision, and final closure is performed only by a competent person via role-based approval and an e-signature.

We cover the life-science workflows you actually need: ECR (Engineering Change Request) and ECO (Engineering Change Order) for design/process/labeling changes; Deviation for GxP events (OOS, process departures or batch non-conformances) with containment, investigation and disposition; Concession Note for controlled “use-as-is” or rework/disposition of affected lots (quarantine, conditional release, expiry and QA sign-off); and OFI (Opportunity for Improvement). Use our templates out of the box or tailor fields (lot/serial, regulatory reporting flags, CAPA links, etc.) and routing to match your SOPs—every record keeps the same role-based approvals and immutable audit trail.

Workflows use routing rules, mandatory fields and role-based permissions to ensure the right reviewers and approvers are involved. Gate logic enforces required signers and conditions and prevents closure until those requirements are met. Part 11-style e-signatures are captured at approval/closure to lock the record, and configurable reassignment/escalation keeps governance timely and auditable.

Change records can be linked to requirements, risks (e.g., ISO 14971), tests, DHF/DMR sections, CAPA, supplier records and training. You can link evidence and supporting documents, and add tasks or training assignments where needed. These links make the impact clear and keep a searchable, auditable chain across product and quality records.

All edits, review/approval comments and attachments are captured as structured events: UTC timestamp, user identity and a draft/version snapshot. An immutable audit trail and approval manifest show who did what and when — so auditors and reviewers can reproduce the change history easily.

Because change submissions are stored as structured JSON, every field is reportable. Pre-built reports and ad-hoc exports let you review open vs closed changes, cycle time by product/site, overdue approvals, rework rates, implementation status and effectiveness check outcomes. You can slice and filter by change type (ECR/ECO/Deviation/Concession/OFI), risk, owner, supplier or product. Export the data to Excel or feed it into your BI tools for charts and Management Review packs — the raw JSON also supports deeper analysis.